Recall Z-0017-2022 ยท NDP Accessories, Implant, Dental, Endosseous
Paltop Advanced Dental Solutions Ltd
Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic de
| Date | Jul 26, 2021 |
| Status | Terminated |
| Reason | Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size engraved on the peek has been identified. Deviations may delay the final restoration. |
| Root cause | Process change control |
| Action | Impacted customers were contacted on July 26, 2021 via overnight delivery of written notification. The firm is replacing all components listed in the recall, purchased prior to 7/21/2021. Customers were asked to complete and return the provided product replacement form. A customer service representative will contact you to evaluate your inventory and to facilitate the exchange immediately. Please contact your Customer Service Department at 866-902-9272 for any questions. |
| Quantity | 68 |
| Distribution | US Nationwide distribution. No foreign distribution from US. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.